MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number H749201003990

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Chest Pain (1776); Occlusion (1984); ST Segment Elevation (2059)

Event Date 01/22/2014

Event Type  Injury  

Event Description

It was reported that vein graft became occluded.The moderately tortuous and moderately calcified lesion was located in the vein graft.A 190cm filterwire ez was used in percutaneous coronary intervention.The physician crossed the lesion area with the device easily; however, when the delivery sheath was attempted to be retracted to deploy the filter basket, resistance was met and deployment was not possible.The device was removed from the vein graft and it was noticed immediately that the graft was occluded.The physician inserted an unspecified guide wire and two unspecified stents; however, this was unsuccessful in restoring flow.Multiple passes with aspiration devices also did not restore blood flow.The patient had chest pain and st elevation.A balloon pump was used.The patient settled down after a few hours.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Corrected from upn h749201001900 to h749201003990.(b)(4).

Event Description

It was reported that vein graft became occluded.The moderately tortuous and moderately calcified lesion was located in the vein graft.A 190cm filterwire ez was used in percutaneous coronary intervention.The physician crossed the lesion area with the device easily; however, when the delivery sheath was attempted to be retracted to deploy the filter basket resistance was met and deployment was not possible.The device was removed from the vein graft and it was noticed immediately that the graft was occluded.The physician inserted an unspecified guide wire and two unspecified stents; however, this was unsuccessful in restoring flow.Multiple passes with aspiration devices also did not restore blood flow.The patient had chest pain and st elevation.A balloon pump was used.The patient settled down after a few hours.

Manufacturer Narrative

Device evaluated by mfr., eval.Summary attached., method code, result code, conclusion code updated.Device evaluated by mfr.: the protection wire and the delivery sheath were returned inside a plastic bag, then inside a double plastic bag.The retrieval sheath was not returned.During the visual and microscopic examination of the returned device, the radiopaque distal tip of the protection wire was found slightly curved.It was not wavy, or stretched.The filter bag was found retracted into the delivery sheath with 1.6 cm of the nosecone exposed and 6 mm of the filter bag exposed.Blood was observed inside the delivery sheath.The wire was found curved and kinked approximately at 131 cm, 135 cm and 136 cm, when measured from the distal tip of the protection wire.The sheath was found curved at approximately 130 cm, when measured from the distal end of the delivery sheath.The sheathing/unsheathing test was unable to be performed because of the wire kinks and the amount of dried blood inside the sheath.The filter bag was observed to be in good condition and met specification.The peel away test was also performed successfully, no anomalies were observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was further reported that the vein graft was very friable and the back and forth with the catheter sheared off some particles that went downstream and occluded the vessel.

• Brand Name: FILTERWIRE EZ?
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3597998
• MDR Text Key: 4169481
• Report Number: 2134265-2014-00547
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2014
• Device Model Number: H749201003990
• Device Catalogue Number: 20100-399
• Device Lot Number: 15639633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention